BeyondSpring Inc.
|
|||
By:
|
/s/ Lan Huang
|
Name:
|
Lan Huang
|
Title:
|
Chairman and Chief Executive Officer
|
Exhibit No.
|
Exhibit
|
|
99.1 |
Press release, dated June 11, 2020.
|
- PROTECTIVE-2 Phase 2 Shows Positive Results in Chemotherapy Optimization with Potentially Better Clinical Outcomes -
• |
In breast cancer patients treated with docetaxel, doxorubicin and cyclophosphamide (TAC, a high-risk chemotherapy) with 20mg/m2 of Plinabulin combined with 6mg of Neulasta (n=16) compared with 6mg of Neulasta alone (n=22),
Plinabulin + G-CSF improved compliance with targeted chemotherapy
|
• |
Dose reduction (over 15 percent): only 6.3 percent of patients in the Plinabulin-Neulasta combination arm versus 22.7 percent in Neulasta arm – a 72 percent improvement
|
• |
Downgraded regimen (from TAC, to docetaxel and cyclophosphamide, or TC): No (0 percent) patients in the Plinabulin + G-CSF arm downgraded chemotherapy from the TAC regimen to the TC regimen versus 18.2 percent in the Neulasta arm – p <
0.05
|
• |
BeyondSpring’s e-publication, titled, “Comparison of CD34+ mobilization effects of standard dose pegfilgrastim (Peg) versus low-dose peg combined with plinabulin (Plin),” demonstrates the efficacy of Plinabulin-Neulasta combination in
increasing CD34+ counts for patients, with fewer adverse events
|
• |
Additionally, BeyondSpring’s poster presentation, titled, “Head-to-head comparison of the non-G-CSF small molecule single agent (SA) plinabulin with SA pegfilgrastim for the prevention of docetaxel chemotherapy (chemo)-induced neutropenia
(CIN) in the protective-1 trial,” compares Plinabulin versus Neulasta as an effective monotherapy for CIN prevention
|
• |
Upon reviewing the efficacy and safety data of over 500 patients at an approximately 300-patient death event, DSMB advised BeyondSpring to continue the study without any modifications
|
• |
DUBLIN-3 is a global Phase 3 trial for Plinabulin, in combination with docetaxel versus docetaxel alone, for the treatment of second- / third-line EGFR wild-type NSCLC
|
• |
Thus far, over 600 cancer patients have been dosed with Plinabulin, which has demonstrated good tolerability and satisfies the safety database standard of both the U.S. Food and Drug Administration (FDA) and China’s National Medical
Products Administration (NMPA)
|
• |
In May 2020, the U.S. Patent and Trademark Office (USPTO) granted BeyondSpring a new patent for methods of treating severe CIN in cancer patients treated with taxane with protection through 2033. This patent establishes Plinabulin’s
beneficial effects in reducing CIN associated with taxane, one of the most commonly used chemotherapies
|
• |
The Company currently owns 76 patents, including 17 issued U.S. patents, for Plinabulin and its analogs with protection through 2036
|
• |
Interim topline data readout for PROTECTIVE-2 Phase 3 for CIN – June 2020
|
• |
Final data readout for PROTECTIVE-2 Phase 3 for CIN – H2 2020
|
• |
Final data readout for PROTECTIVE-1 Phase 3 for CIN – H2 2020
|
• |
NDA submission for Plinabulin for CIN in the U.S. – H2 2020
|
• |
Final data readout for DUBLIN-3 for NSCLC – H2 2020
|
• |
NDA submission for Plinabulin for NSCLC in China – H2 2020
|
• |
NDA submission for Plinabulin for NSCLC in the U.S. – H1 2021
|
December 31,
|
March 31,
|
||||||||||
Note
|
2019
|
2020
|
|||||||||
|
$ |
|
$ | ||||||||
(Unaudited)
|
|||||||||||
Assets
|
|||||||||||
Current assets:
|
|||||||||||
Cash and cash equivalents
|
35,933
|
24,917
|
|||||||||
Advances to suppliers
|
4,519
|
4,384
|
|||||||||
Prepaid expenses and other current assets
|
410
|
452
|
|||||||||
Total current assets
|
40,862
|
29,753
|
|||||||||
Noncurrent assets:
|
|||||||||||
Property and equipment, net
|
3
|
209
|
203
|
||||||||
Operating lease right-of-use assets
|
2,538
|
2,607
|
|||||||||
Other noncurrent assets
|
946
|
941
|
|||||||||
Total noncurrent assets
|
3,693
|
3,751
|
|||||||||
Total assets
|
44,555
|
33,504
|
|||||||||
|
|
||||||||||
Liabilities and equity
|
|||||||||||
Current liabilities:
|
|||||||||||
Accounts payable
|
2,537
|
5,140
|
|||||||||
Accrued expenses
|
5,861
|
4,697
|
|||||||||
Due to related parties
|
5
|
29
|
42
|
||||||||
Current portion of operating lease liabilities
|
537
|
643
|
|||||||||
Other current liabilities
|
11
|
1,089
|
1,685
|
||||||||
Total current liabilities
|
10,053
|
12,207
|
|||||||||
Noncurrent liabilities:
|
|||||||||||
Long-term loans
|
4
|
1,436
|
1,413
|
||||||||
Operating lease liabilities
|
1,935
|
1,892
|
|||||||||
Total noncurrent liabilities
|
3,371
|
3,305
|
|||||||||
Total liabilities
|
13,424
|
15,512
|
|||||||||
Equity:
|
|||||||||||
Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 27,885,613 shares and 27,888,906 shares issued and outstanding as of December 31, 2019 and March 31, 2020, respectively)
|
7
|
3
|
3
|
||||||||
Additional paid-in capital
|
7
|
246,979
|
250,417
|
||||||||
Accumulated deficit
|
7
|
(216,845
|
)
|
(232,929
|
)
|
||||||
Accumulated other comprehensive income
|
7
|
140
|
197
|
||||||||
|
|||||||||||
Total BeyondSpring Inc.’s shareholder’s equity
|
30,277
|
17,688
|
|||||||||
Noncontrolling interests
|
7
|
854
|
304
|
||||||||
Total equity
|
31,131
|
17,992
|
|||||||||
Total liabilities and equity
|
44,555
|
33,504
|
Three months ended March 31,
|
|||||||||||
Note
|
2019
|
2020
|
|||||||||
|
$ |
|
$ | ||||||||
-
|
-
|
||||||||||
Operating expenses:
|
|||||||||||
Research and development
|
(6,330
|
)
|
(13,704
|
)
|
|||||||
Selling, general and administrative
|
(1,639
|
)
|
(2,928
|
)
|
|||||||
Loss from operations
|
(7,969
|
)
|
(16,632
|
)
|
|||||||
Foreign exchange gain (loss), net
|
173
|
(74
|
)
|
||||||||
Interest income
|
6
|
64
|
|||||||||
Interest expense
|
(37
|
)
|
(21
|
)
|
|||||||
Other income
|
-
|
1
|
|||||||||
Loss before income tax
|
(7,827
|
)
|
(16,662
|
)
|
|||||||
Income tax benefit
|
6
|
-
|
-
|
||||||||
Net loss
|
(7,827
|
)
|
(16,662
|
)
|
|||||||
Less: Net loss attributable to noncontrolling interests
|
(534
|
)
|
(578
|
)
|
|||||||
Net loss attributable to BeyondSpring Inc.
|
(7,293
|
)
|
(16,084
|
)
|
|||||||
Net loss per share
|
|||||||||||
Basic and diluted
|
10
|
(0.32
|
)
|
(0.58
|
)
|
||||||
Weighted-average shares outstanding Basic and diluted
|
10
|
23,029,362
|
27,732,449
|
||||||||
|
|
||||||||||
Other comprehensive loss
|
|||||||||||
Foreign currency translation adjustment (loss) gain
|
(194
|
)
|
53
|
||||||||
Comprehensive loss
|
(8,021
|
)
|
(16,609
|
)
|
|||||||
Less: Comprehensive loss attributable to noncontrolling interests
|
(575
|
)
|
(582
|
)
|
|||||||
Comprehensive loss attributable to BeyondSpring Inc.
|
(7,446
|
)
|
(16,027
|
)
|
Three months ended March 31,
|
|||||||||||
Note
|
2019
|
2020
|
|||||||||
|
$ |
|
$ | ||||||||
Operating activities:
|
|||||||||||
Net loss
|
(7,827
|
)
|
(16,662
|
)
|
|||||||
Adjustments to reconcile net loss to net cash from operating activities:
|
|||||||||||
Share-based compensation
|
12
|
371
|
3,470
|
||||||||
Depreciation expenses
|
23
|
15
|
|||||||||
Changes in operating assets and liabilities:
|
|||||||||||
Advances to suppliers
|
143
|
135
|
|||||||||
Due from related parties
|
5
|
100
|
-
|
||||||||
Prepaid expenses and other current assets
|
123
|
(42
|
)
|
||||||||
Operating lease right-of-use assets
|
134
|
(69
|
)
|
||||||||
Other noncurrent assets
|
(60
|
)
|
5
|
||||||||
Accounts payable
|
(620
|
)
|
2,603
|
||||||||
Accrued expenses
|
2,377
|
(1,164
|
)
|
||||||||
Operating lease liabilities
|
(56
|
)
|
63
|
||||||||
Other current liabilities
|
232
|
596
|
|||||||||
Net cash used in operating activities
|
(5,060
|
)
|
(11,050
|
)
|
|||||||
|
|
||||||||||
Investing activities:
|
|||||||||||
Acquisitions of property and equipment
|
(4
|
)
|
(9
|
)
|
|||||||
Net cash used in investing activities
|
(4
|
)
|
(9
|
)
|
|||||||
Financing activities:
|
|||||||||||
Proceeds from loans
|
4
|
2,986
|
-
|
||||||||
Loans from related parties
|
5
|
350
|
14
|
||||||||
Net cash provided by financing activities
|
3,336
|
14
|
|||||||||
Effect of foreign exchange rate changes, net
|
(200
|
)
|
29
|
||||||||
Net decrease in cash and cash equivalents
|
(1,928
|
)
|
(11,016
|
)
|
|||||||
Cash at beginning of period
|
3,889
|
35,933
|
|||||||||
Cash at end of period
|
1,961
|
24,917
|
1. |
Nature of the business and basis of preparation
|
Name of company
|
Place of incorporation
|
Date of
incorporation
|
Percentage of
ownership by the
Company
|
Principal
activities
|
BeyondSpring
|
Delaware,
|
|||
Pharmaceuticals Inc.
|
United States of America (“U.S.”)
|
June 18, 2013
|
100%
|
Clinical trial activities
|
BeyondSpring Ltd.
|
The British Virgin Islands (“BVI”)
|
December 3, 2014
|
100%
|
Holding company
|
BeyondSpring (HK) Limited
|
Hong Kong
|
January 13, 2015
|
100%
|
Holding company
|
Wanchun Biotechnology
|
||||
Limited
|
BVI
|
April 1, 2015
|
100%
|
Holding company
|
Wanchun Biotechnology
|
The People’s Republic of China
|
|||
(Shenzhen) Ltd.
|
(“PRC”)
|
April 23, 2015
|
100%
|
Holding company
|
Dalian Wanchunbulin
|
||||
Pharmaceuticals Ltd.
|
||||
(“Wanchunbulin”)
|
PRC
|
May 6, 2015
|
57.97%
|
Clinical trial activities
|
BeyondSpring Pharmaceuticals
|
||||
Australia PTY Ltd.
|
||||
(“BeyondSpring Australia”)
|
Australia
|
March 3, 2016
|
100%
|
Clinical trial activities
|
Beijing Wanchun Pharmaceutical
|
||||
Technology Ltd.
|
||||
(“Beijing Wanchun”)
|
PRC
|
May 21, 2018
|
57.97%
|
Clinical trial activities
|
SEED Therapeutics Inc.
|
||||
(“SEED”)
|
BVI
|
June 25, 2019
|
100%
|
Holding company
|
SEED Technology Limited
|
||||
(“SEED Technology”)
|
BVI
|
December 9, 2019
|
57.97%
|
Holding company
|
1. |
Nature of the business and basis of preparation (continued)
|
2. |
Summary of significant accounting policies
|
2. |
Summary of significant accounting policies (continued)
|
• |
Level 1— Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.
|
• |
Level 2— Other inputs that are directly or indirectly observable in the marketplace.
|
• |
Level 3— Unobservable inputs which are supported by little or no market activity.
|
3. |
Property and equipment, net
|
December 31,
2019
|
March 31,
2020
|
|||||||
|
$ |
|
$ | |||||
(Unaudited)
|
||||||||
Office equipment
|
150
|
161
|
||||||
Laboratory equipment
|
114
|
113
|
||||||
Motor vehicles
|
23
|
22
|
||||||
Leasehold improvements
|
103
|
103
|
||||||
390
|
399
|
|||||||
Less: accumulated depreciation
|
(181
|
)
|
(196
|
)
|
||||
Property and equipment, net
|
209
|
203
|
4. |
Long-term loans
|
5. |
Related party transactions
|
6. |
Income taxes
|
7. |
Equity
|
BeyondSpring Inc.’s shareholders
|
||||||||||||||||||||||||||||||||
|
|
Accumulated
|
|
|
||||||||||||||||||||||||||||
Additional
|
other
|
Non
|
Total
|
|||||||||||||||||||||||||||||
Ordinary share
|
paid-in
|
Accumulated |
comprehensive
|
Subtotal |
controlling
|
equity
|
||||||||||||||||||||||||||
Shares
|
Amount
|
capital
|
deficit
|
(loss) gain
|
interests
|
(deficit)
|
||||||||||||||||||||||||||
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
$ | |||||||||||||||||||
Balances at January 1, 2020 (audited)
|
27,885,613
|
3
|
246,979
|
(216,845
|
)
|
140
|
30,277
|
854
|
31,131
|
|||||||||||||||||||||||
Share-based compensation
|
3,293
|
-
|
3,438
|
-
|
-
|
3,438
|
32
|
3,470
|
||||||||||||||||||||||||
Foreign currency translation adjustment (loss) gain
|
-
|
-
|
-
|
-
|
57
|
57
|
(4
|
)
|
53
|
|||||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(16,084
|
)
|
-
|
(16,084
|
)
|
(578
|
)
|
(16,662
|
)
|
||||||||||||||||||||
Balances at March 31, 2020 (unaudited)
|
27,888,906
|
3
|
250,417
|
(232,929
|
)
|
197
|
17,688
|
304
|
17,992
|
|||||||||||||||||||||||
Balances at January 1, 2019 (audited)
|
23,184,612
|
2
|
170,950
|
(178,760
|
)
|
42
|
(7,766
|
)
|
(1,616
|
)
|
(9,382
|
)
|
||||||||||||||||||||
Share-based compensation
|
-
|
-
|
371
|
-
|
-
|
371
|
-
|
371
|
||||||||||||||||||||||||
Foreign currency translation adjustment loss
|
-
|
-
|
-
|
-
|
(153
|
)
|
(153
|
)
|
(41
|
)
|
(194
|
)
|
||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(7,293
|
)
|
-
|
(7,293
|
)
|
(534
|
)
|
(7,827
|
)
|
||||||||||||||||||||
Balances at March 31, 2019 (unaudited)
|
23,184,612
|
2
|
171,321
|
(186,053
|
)
|
(111
|
)
|
(14,841
|
)
|
(2,191
|
)
|
(17,032
|
)
|
8. |
Restricted net assets
|
9. |
Employee defined contribution plan
|
10. |
Net loss per share
|
|
Three months ended March 31,
|
|||||||
2019
|
2020
|
|||||||
(Unaudited)
|
(Unaudited)
|
|||||||
Numerator:
|
||||||||
Net loss attributable to BeyondSpring Inc.—basic and diluted
|
|
$ |
(7,293
|
) |
$
|
(16,084 |
)
|
|
|
||||||||
Denominator:
|
||||||||
Weighted average number of ordinary shares outstanding—basic and diluted
|
23,029,362
|
27,732,449
|
||||||
|
||||||||
Net loss per share —basic and diluted
|
$
|
(0.32
|
)
|
$ | (0.58) |
11. |
Supplemental balance sheet information
|
As of December 31,
|
As of March 31,
|
|||||||
2019
|
2020
|
|||||||
|
$ |
|
$ | |||||
|
(Unaudited)
|
|||||||
Compensation related
|
226
|
207
|
||||||
Professional services
|
-
|
543
|
||||||
Other taxes related
|
798
|
810
|
||||||
Other
|
65
|
125
|
||||||
|
||||||||
Total
|
1,089
|
1,685
|
12. |
Share-based compensation
|
Three months ended March 31,
|
||||||||
2019
|
2020 | |||||||
|
$ |
|
$ | |||||
|
(Unaudited)
|
|
(Unaudited)
|
|||||
Research and development
|
156
|
3,183
|
||||||
Selling, general and administrative
|
215
|
287
|
||||||
Total
|
371
|
3,470
|
Note 12 - Share-based Compensation (Details Textual) |
3 Months Ended |
---|---|
Mar. 31, 2020
shares
| |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross (in shares) | 381,301 |
Restricted Stock [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period (in shares) | 3,293 |
Note 8 - Restricted Net Assets (Details Textual) - USD ($) $ in Thousands |
Mar. 31, 2020 |
Dec. 31, 2019 |
---|---|---|
Restricted Net Assets | $ 329 | $ 2,032 |
Significant Accounting Policies (Policies) |
3 Months Ended | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2020 | ||||||||||
Accounting Policies [Abstract] | ||||||||||
Basis of Accounting, Policy [Policy Text Block] | Basis of consolidation The unaudited interim condensed consolidated financial statements include the financial statements of the Company and its subsidiaries. All significant intercompany transactions and balances between the Company and its subsidiaries are eliminated upon consolidation. |
|||||||||
Going Concern, Policy [Policy Text Block} | Going concern According to Accounting Standards Codification (“ASC”) 205 -40, Presentation of Financial Statements - Going Concern (“ASC 205 -40” ), management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1 ) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2 ) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued.The Company has incurred operating losses and negative cash flows from operations since inception. To date, the Company has no product revenue and management expects operating losses to continue for the foreseeable future, and has primarily funded these losses through equity financings. The Company incurred a net loss of $16,662 during the three months ended March 31, 2020 and has an accumulated deficit of $232,929 as of March 31, 2020. Net cash used in operations was approximately $11,050 for the three months ended March 31, 2020. As of March 31, 2020, the Company had $17,546 net current assets and $24,917 of cash and cash equivalents on hand.The Company is implementing a cost reduction plan, which includes the deferral of certain research, development and clinical projects and reduction of administrative expenses until it obtains additional financings. With the implementation of cost reduction plan, the Company anticipates that its current financial resources will enable it to meet its operational expenses and capital expenditures into the second quarter of year 2021. Therefore, the management believes that the substantial doubt about the Company’s ability to continue as a going concern within one year after the date the financial statements are issued has been alleviated. The accompanying unaudited interim condensed consolidated financial statements have been prepared on a going concern basis. |
|||||||||
Use of Estimates, Policy [Policy Text Block] | Use of estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to share-based compensation, clinical trial accrual, valuation allowance for deferred tax assets, estimating uncertain tax position, measurement of right of use assets and lease liabilities and estimating of useful life for property and equipment. Management bases the estimates on historical experience, known trends and various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from these estimates. |
|||||||||
Fair Value of Financial Instruments, Policy [Policy Text Block] | Fair value measurements The Company measures certain financial assets and liabilities at fair value. Fair value is determined based upon the exit price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants, as determined by either the principal market or the most advantageous market. Inputs used in the valuation techniques to derive fair values are classified based on a three -level hierarchy, as follows:
ASC 820, Fair Value Measurements and Disclosures (“ASC 820” ) describes three main approaches to measuring the fair value of assets and liabilities: (1 ) market approach; (2 ) income approach and (3 ) cost approach. The market approach uses prices and other relevant information generated from market transactions involving identical or comparable assets or liabilities. The income approach uses valuation techniques to convert future amounts to a single present value amount. The measurement is based on the value indicated by current market expectations about those future amounts. The cost approach is based on the amount that would currently be required to replace an asset.Financial instruments of the Company primarily include cash and cash equivalents, due from related parties, due to related parties, accounts payable and long-term loans. Except for the long-term loans, the carrying values of these financial instruments approximated their fair value due to their short term nature as of December 31, 2019 and March 31, 2020. As of December 31, 2019 and March 31, 2020, the total carrying amount of long-term loans was $1,436 and $1,413, compared with an estimated fair value of $1,373 and $1,214, respectively. The fair value of the long-term loans is estimated by discounting cash flows using interest rates currently available for debts with similar terms and maturities (Level 2 fair value measurement). |
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New Accounting Pronouncements, Policy [Policy Text Block] | Recent accounting pronouncements New accounting standard have not yet been adoptedIn December 2019, the FASB issued ASU 2019 -12, Income Taxes (Topic ): Simplifying the Accounting for Income Taxes. This update simplifies the accounting for income taxes as part of the FASB’s overall initiative to reduce complexity in accounting standards. The amendments include removal of certain exceptions to the general principles of ASC 740 740, and simplification in several other areas such as accounting for a franchise tax (or similar tax) that is partially based on income. The update is effective in fiscal years beginning after December 15, 2020, and interim periods therein, and early adoption is permitted. Certain amendments in this update should be applied retrospectively or modified retrospectively, all other amendments should be applied prospectively. The Company is currently evaluating the impact on its financial statements of adopting this guidance. |
Note 5 - Related Party Transactions |
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Notes to Financial Statements | ||||
Related Party Transactions Disclosure [Text Block] |
Loan from related parties In October and December 2019, the Company borrowed 60 -day interest-free loans totaling of $29 (RMB200 ) from Dalian Wanchun Biotechnology Co., Ltd. (“Wanchun Biotech”). In February 2020, the Company borrowed 60 -day interest-free loans totaling of $14 (RMB100 ) from Wanchun Biotech. The maturity of the above loans was extended to June 2020. |
Note 9 - Employee Defined Contribution Plan |
3 Months Ended | |||
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Mar. 31, 2020 | ||||
Notes to Financial Statements | ||||
Compensation and Employee Benefit Plans [Text Block] |
Full time employees of the Company in the PRC participate in a government mandated defined contribution plan, pursuant to which certain pension benefits, medical care, employee housing fund and other welfare benefits are provided to employees. Chinese labor regulations require that the Company’s PRC subsidiaries make contributions to the government for these benefits based on certain percentages of the employees’ salaries. The Company has no legal obligation for the benefits beyond the contributions made. The total amounts for such employee benefits, which were expensed as incurred, were $15 and $26 for the three months ended March 31, 2019 and 2020, respectively. |
Audited Consolidated Balance Sheet as of December 31, 2019 and Unaudited Interim Condensed Consolidated Balance Sheet as of March 31, 2020 (Parentheticals) - $ / shares |
Mar. 31, 2020 |
Dec. 31, 2019 |
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Ordinary shares, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Ordinary shares, authorized (in shares) | 500,000,000 | 500,000,000 |
Ordinary shares, issued (in shares) | 27,888,906 | 27,885,613 |
Ordinary shares, outstanding (in shares) | 27,888,906 | 27,885,613 |
Note 2 - Summary of Significant Accounting Policies |
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Significant Accounting Policies [Text Block] |
Basis of consolidation The unaudited interim condensed consolidated financial statements include the financial statements of the Company and its subsidiaries. All significant intercompany transactions and balances between the Company and its subsidiaries are eliminated upon consolidation. Going concern According to Accounting Standards Codification (“ASC”) 205 -40, Presentation of Financial Statements - Going Concern (“ASC 205 -40” ), management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1 ) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2 ) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued.The Company has incurred operating losses and negative cash flows from operations since inception. To date, the Company has no product revenue and management expects operating losses to continue for the foreseeable future, and has primarily funded these losses through equity financings. The Company incurred a net loss of $16,662 during the three months ended March 31, 2020 and has an accumulated deficit of $232,929 as of March 31, 2020. Net cash used in operations was approximately $11,050 for the three months ended March 31, 2020. As of March 31, 2020, the Company had $17,546 net current assets and $24,917 of cash and cash equivalents on hand.The Company is implementing a cost reduction plan, which includes the deferral of certain research, development and clinical projects and reduction of administrative expenses until it obtains additional financings. With the implementation of cost reduction plan, the Company anticipates that its current financial resources will enable it to meet its operational expenses and capital expenditures into the second quarter of year 2021. Therefore, the management believes that the substantial doubt about the Company’s ability to continue as a going concern within one year after the date the financial statements are issued has been alleviated. The accompanying unaudited interim condensed consolidated financial statements have been prepared on a going concern basis.Use of estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to share-based compensation, clinical trial accrual, valuation allowance for deferred tax assets, estimating uncertain tax position, measurement of right of use assets and lease liabilities and estimating of useful life for property and equipment. Management bases the estimates on historical experience, known trends and various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from these estimates.Fair value measurements The Company measures certain financial assets and liabilities at fair value. Fair value is determined based upon the exit price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants, as determined by either the principal market or the most advantageous market. Inputs used in the valuation techniques to derive fair values are classified based on a three -level hierarchy, as follows:
ASC 820, Fair Value Measurements and Disclosures (“ASC 820” ) describes three main approaches to measuring the fair value of assets and liabilities: (1 ) market approach; (2 ) income approach and (3 ) cost approach. The market approach uses prices and other relevant information generated from market transactions involving identical or comparable assets or liabilities. The income approach uses valuation techniques to convert future amounts to a single present value amount. The measurement is based on the value indicated by current market expectations about those future amounts. The cost approach is based on the amount that would currently be required to replace an asset.Financial instruments of the Company primarily include cash and cash equivalents, due from related parties, due to related parties, accounts payable and long-term loans. Except for the long-term loans, the carrying values of these financial instruments approximated their fair value due to their short term nature as of December 31, 2019 and March 31, 2020. As of December 31, 2019 and March 31, 2020, the total carrying amount of long-term loans was $1,436 and $1,413, compared with an estimated fair value of $1,373 and $1,214, respectively. The fair value of the long-term loans is estimated by discounting cash flows using interest rates currently available for debts with similar terms and maturities (Level 2 fair value measurement).Recent accounting pronouncements New accounting standard have not yet been adoptedIn December 2019, the FASB issued ASU 2019 -12, Income Taxes (Topic ): Simplifying the Accounting for Income Taxes. This update simplifies the accounting for income taxes as part of the FASB’s overall initiative to reduce complexity in accounting standards. The amendments include removal of certain exceptions to the general principles of ASC 740 740, and simplification in several other areas such as accounting for a franchise tax (or similar tax) that is partially based on income. The update is effective in fiscal years beginning after December 15, 2020, and interim periods therein, and early adoption is permitted. Certain amendments in this update should be applied retrospectively or modified retrospectively, all other amendments should be applied prospectively. The Company is currently evaluating the impact on its financial statements of adopting this guidance. |
Note 10 - Net Loss Per Share (Tables) |
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Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] |
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Note 2 - Summary of Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands |
3 Months Ended | 12 Months Ended | ||
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Mar. 31, 2020 |
Mar. 31, 2019 |
Dec. 31, 2019 |
Dec. 31, 2018 |
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Revenue from Contract with Customer, Including Assessed Tax | $ 0 | |||
Net Income (Loss), Including Portion Attributable to Noncontrolling Interest, Total | (16,662) | (7,827) | ||
Retained Earnings (Accumulated Deficit), Ending Balance | (232,929) | (216,845) | ||
Net Cash Provided by (Used in) Operating Activities, Total | (11,050) | (5,060) | ||
Net Current Assets | 17,546 | |||
Cash and Cash Equivalents, at Carrying Value, Ending Balance | 24,917 | $ 1,961 | 35,933 | $ 3,889 |
Long-term Debt, Total | 1,413 | 1,436 | ||
Long-term Debt, Fair Value | $ 1,214 | $ 1,373 |
Note 1 - Nature of the Business and Basis of Preparation |
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Nature of Operations [Text Block] |
BeyondSpring Inc. (the “Company”) was incorporated in the Cayman Islands on November 21, 2014. The Company and its subsidiaries (collectively, the “Group”) are principally engaged in clinical stage biopharmaceutical activities focusing on the development of innovative cancer therapies. The Company is under the control of Mr. Linqing Jia and Dr. Lan Huang as a couple (collectively, the “Founders”) since its incorporation.As of March 31, 2020, the subsidiaries of the Company are as follows:
The accompanying unaudited interim condensed consolidated balance sheet as of March 31, 2020, the unaudited interim condensed consolidated statements of comprehensive loss for the three months ended March 31, 2019 and 2020, the cash flows for the three months ended March 31, 2019 and 2020, and the related footnote disclosures are unaudited. These unaudited interim condensed consolidated financial statements of the Company have been prepared in accordance with U.S. GAAP for interim financial information using accounting policies that are consistent with those used in the preparation of the Company’s audited consolidated financial statements for the year ended December 31, 2019. Accordingly, these unaudited interim condensed consolidated financial statements do not include all of the information and footnotes required by U.S. GAAP for annual financial statements.In the opinion of management, the accompanying unaudited interim condensed consolidated financial statements contain all normal recurring adjustments necessary to present fairly the financial position, operating results and cash flows of the Group for each of the periods presented. The results of operations for the three months ended March 31, 2020 are not necessarily indicative of results to be expected for any other interim period or for the full year of 2020. The consolidated balance sheet as of December 31, 2019 was derived from the audited consolidated financial statements at that date but does not include all of the disclosures required by U.S. GAAP for annual financial statements. These unaudited interim condensed consolidated financial statements should be read in conjunction with the Company’s consolidated financial statements for the year ended December 31, 2019. |
Note 11 - Supplemental Balance Sheet Information (Tables) |
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Other Current Liabilities [Table Text Block] |
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Note 3 - Property and Equipment, Net (Details Textual) - USD ($) $ in Thousands |
3 Months Ended | |
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Mar. 31, 2020 |
Mar. 31, 2019 |
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Depreciation, Total | $ 15 | $ 23 |
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